MAUDE Adverse Event Report: SYNTHES GMBH 9MM TI CANNULATED HUMERAL NAIL-EX/260MM-STERILE; NAIL,FIXATION,BONE

Catalog Number 04.001.432S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent surgery for fracture of shaft of left humerus with the nail.During the surgery, when the surgeon was marking with a gimlet for a locking screw insertion, supracondylar fracture of left humerus occurred.The surgery was completed with no surgical delay.No further information is available.This complaint involves one (1) device.This report is for (1) 9mm ti cannulated humeral nail-ex/260mm-sterile.This is report 1 of 1 or complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part #: 04.001.432s, lot #: 8l09249, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 19-apr-2021, expiry date: 01-apr-2031.Non-sterile part: part #: 04.001.432, lot #: 96p8798.Manufacturing location: (b)(4), manufacturing date: 20-mar-2021, part number: 04.001.432, 9mm ti cannulated humeral nail-ex/260mm, lot number: 96p8798 (non-sterile), lot quantity: 4.Two pieces were scrapped in cell at op #110, final inspection, due to cannulation burrs.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, in-process / inspect dimensional / final, (b)(4) rev b met all inspection acceptance criteria apart from the two pieces noted.Packaging label log (pll) lmd rev ad was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿extra bleeding (small amount) occurred¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: 17-nov-2021: dhr reviewed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9MM TI CANNULATED HUMERAL NAIL-EX/260MM-STERILE
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12961563
• MDR Text Key: 281925705
• Report Number: 8030965-2021-10041
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819782990
• UDI-Public: (01)07611819782990
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.001.432S
• Device Lot Number: 8L09249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 62 KG